Module 15 2022

19/05/2022

Language: Patient

• Readability: At the level of intended user • Implant/Patient use device SSCPs must have a patient section. • Assumed reader does not have any formal education in medical field/clinical research. • MDR: Article 2: (38) ‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline. • Medical terms: Explained in simple language, lay term/description (medical term).

A heart attack (myocardial infarction or MI) is a serious medical emergency in which the supply of blood to the heart is suddenly blocked, usually by a blood clot. A lack of blood to the heart may seriously damage the heart muscle and can be life threatening. https://www.nhs.uk/conditions/heart-attack/

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

17

Language: Readability Assessment

• Readability: Manufacturer to define the appropriate assessment. • MDCG 2019-9 recommends a test given by lay persons. • Includes reference to “Summaries of Clinical Trials Results for Laypersons”. • This article discusses “Flesch Reading Ease Test or the Flesch-Kincaid Grade Level Tests”

Readability Test Easy to read Flesch-Kincaid Grade Level Test 6 th grade

Flesch Reading Ease Test

>70

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

18

9